Full Press Release Details
Arcutis Announces First Quarter 2020 Financial Results and Provides Business Update
Westlake Village, CA, May 12, 2020 Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today reported financial results for the quarter ended March 31,
2020 and provided a business update.
Despite the global challenges presented by COVID-19, Arcutis continued
to make progress in executing upon our mission of addressing the gap we see in dermatology drug development by leveraging recent advances in inflammation and immunology, said Frank Watanabe, Arcutis President and Chief Executive Officer.
Our priorities during these unprecedented times are first and foremost to safeguard the health and well-being of our trial participants, investigators, and employees; then to continue effective operations to support our clinical trial sites
and to advance our pipeline of drug candidates; and to maintain the financial strength and stability afforded us by our recent successful initial public offering. Although some of our clinical sites have experienced disruptions as a result of COVID-19, at this time we do not expect delays to any of our previously disclosed clinical timelines, and we still expect to have six clinical data readouts over the next 18 months, including our pivotal Phase 3
clinical trials of topical roflumilast cream as a potential treatment for plaque psoriasis. We currently have four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients.
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com
Topical roflumilast cream (ARQ-151) - a highly potent and selective phosphodiesterase type 4
(PDE4) inhibitor in a cream formulation, being developed as a potential treatment for plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis.
Topical roflumilast foam (ARQ-154)
- a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a foam formulation, designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, being developed as a potential treatment for
seborrheic dermatitis and scalp psoriasis.
ARQ-252 - a potent and highly
selective topical small molecule inhibitor of janus kinase type 1 (JAK1), being developed as a potential treatment for chronic hand eczema and other inflammatory dermatoses.
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com
ARQ-255 - an alternative topical formulation of ARQ-252 designed to reach deeper into the skin in order to potentially treat alopecia areata.
Recent Corporate Highlights
First Quarter 2020 Summary Financial Results
cash equivalents and marketable securities were $249.3 million as of March 31, 2020, compared to $101.3 million as of December 31, 2019. Arcutis believes that its current cash, cash equivalents and marketable securities, will
be sufficient to fund its operations through 2021.
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com
Research and development (R&D) expenses for the quarter ended March 31, 2020 were $25.2 million
compared to $6.2 million for the corresponding period in 2019. The increase was primarily due to the initiation of multiple clinical trials during the last year.
General and administrative (G&A) expenses for the quarter ended March 31, 2020 were $3.5 million compared to $0.7 million for the
corresponding period in 2019. The increase was due to higher headcount and professional services costs.
Net loss was $28.0 million, or $1.15
per basic and diluted share, for the first quarter of 2020 compared to $6.7 million, or $4.08 per basic and diluted share, for the first quarter of 2019.
About Arcutis - Bioscience, applied to the skin.
is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. Arcutis exploits recent innovations in inflammation and
immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization
expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds, including topical roflumilast cream (ARQ-151), topical roflumilast foam (ARQ-154), and ARQ-252 for multiple indications, including psoriasis, atopic dermatitis, seborrheic
dermatitis, and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements, including, among others, statements regarding the potential for its topical drugs in
development to address large markets with significant
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com
unmet need; expectations with regard to the timing of data events anticipated during 2020/2021; and the company s
belief that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations through 2021. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and
uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a
further description of the risks and uncertainties applicable to our business, see the Risk Factors section of our Form 10-Q to be filed with U.S. Securities and Exchange Commission (SEC) on
May 12, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Heather Rowe Armstrong Vice President, Investor
Relations & Corporate Communications
805-418-5006, Ext. 740
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Balance Sheets
(In thousands, except share and par value)
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 190,893 | $ | 63,336 | ||||
| Marketable securities | 58,426 | 37,929 | ||||||
| Prepaid expenses and other current assets | 4,559 | 5,209 | ||||||
| Total current assets | 253,878 | 106,474 | ||||||
| Property, plant, and equipment, net | 241 | 227 | ||||||
| Operating lease right-of-use asset | 226 | 264 | ||||||
| Other assets | 47 | 47 | ||||||
| Total assets | $ | 254,392 | $ | 107,012 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,759 | $ | 1,405 | ||||
| Accrued liabilities | 7,281 | 3,654 | ||||||
| Operating lease liability | 182 | 178 | ||||||
| Total current liabilities | 12,222 | 5,237 | ||||||
| Operating lease liability, noncurrent | 82 | 129 | ||||||
| Other long-term liabilities | 206 | 184 | ||||||
| Total liabilities | 12,510 | 5,550 | ||||||
| Convertible preferred stock, $0.0001 par value; no shares and 48,787,898 shares authorized at March 31, 2020 and December 31, 2019, respectively; no shares and 24,385,388 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 166,491 | |||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 and no shares authorized at March 31, 2020 and December 31, 2019, respectively; no shares issued and outstanding at March 31, 2020 and December 31, 2019; | ||||||||
| Common stock, $0.0001 par value; 300,000,000 and 65,820,000 shares authorized at March 31, 2020 and December 31, 2019, respectively; 38,154,550 and 2,879,763 shares issued at March 31, 2020 and December 31, 2019, respectively; 37,471,997 and 2,120,853 shares outstanding at March 31, 2020 and December 31, 2019, respectively | 3 | |||||||
| Additional paid-in capital | 336,145 | 1,244 | ||||||
| Accumulated other comprehensive income (loss) | 19 | (1 | ) | |||||
| Accumulated deficit | (94,285 | ) | (66,272 | ) | ||||
| Total stockholders equity (deficit) | 241,882 | (65,029 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 254,392 | $ | 107,012 |
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 25,182 | $ | 6,203 | ||||
| General and administrative | 3,469 | 749 | ||||||
| Total operating expenses | 28,651 | 6,952 | ||||||
| Loss from operations | (28,651 | ) | (6,952 | ) | ||||
| Other income, net | 638 | 294 | ||||||
| Net loss | $ | (28,013 | ) | $ | (6,658 | ) | ||
| Per share information: | ||||||||
| Net loss per share, basic and diluted | $ | (1.15 | ) | $ | (4.08 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 24,256,402 | 1,632,694 |
2945 Townsgate Road,
Suite 110 | Westlake Village, CA 91361 | arcutis.com